Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease

N/ANot Yet RecruitingNCT06360939

Western Sydney Local Health District60 enrolled

Overview

The goal of this randomized clinical trial is to test the efficacy of stereotactic body radiation therapy (SBRT) in treating ventricular tachycardia (VT) in patients with advanced structural heart disease. The main questions it aims to answer are: * What is the efficacy of SBRT compared to catheter ablation (CA) in achieving a ≥ 75% reduction in VT burden at 6 months * What is the comparable safety profile of SBRT vs CA Researchers will compare SBRT and CA (standard of care).

Hypothesis We hypothesise that in an open label randomised controlled trial of patients with advanced structural heart disease and ventricular tachycardia (VT) that stereotactic body radiation therapy (SBRT) will be superior in reducing VT burden compared to standard care comprising of catheter ablation (CA) and routine medical care with acceptable safety and adverse events. Aims This is a trial to examine if in an open label randomised trial of 60 patients with structural heart disease and VT followed for 3 years with a minimum follow up of 1 year of SBRT compared CA results in: 1. An improvement in a primary outcome of proportion of patients with a ≥75% reduction in VT burden in the 6 months following intervention compared to the 6 months intervention 2. Comparable safety profile (serious adverse events \[SAE\] and adverse events of special interest \[AESI\] at 6 months; 3. reduction in secondary endpoints at 6, 12, 24 and 36 months of: any VT recurrence, absolute % reduction in VT burden compared to 6 months pre-treatment, number of anti-arrhythmic drugs (AADs) compared to pre-treatment, cardiovascular hospitalisation, all-cause mortality, cardiac transplantation, combined endpoint of cardiovascular hospitalisation/transplant/mortality, SAE and AESI from treatment, ventricular function abd change of quality of life (QOL) metrics (at 12 months).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Structural heart disease (including ischaemic cardiomyopathy , non-ischaemic cardiomyopathy or congenital heart disease and defined as any one of 1. segmental or global decreased ventricular wall motion as defined by TTE, CT or cMRI 2. myocardial hypertrophy 3. myocardial scar (evidenced by late gadolinium enhancement on cMRI, wall thinning on cardiac CT, low voltage on electrophysiological study or abnormal intracardiac echocardiography) 2. Recurrent monomorphic VT which can include 1. at least one episode of VT treated by ICD and/or 2. sustained VT (lasting \>30s) and/or 3. inducible sustained VT on invasive electrophysiological study (EPS) or non-invasive programmed stimulation (NIPS) 3. PAINESD score of ≥9 points and/or at least moderate risk of VT recurrence or death as defined by the I-VT score. Both are validated tools used clinically to identify patient at high risk of VT recurrence and/or mortality after CA. Exclusion Criteria: 1. Age \< 18 years 2. Life expectancy \< 3 months 3. Catheter ablation deemed futile or with prohibitive risk by cardiac electrophysiologist. 4. Unwilling or unable to provide consent 5. Known cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome) 6. Contraindications to radiotherapy as deemed by referring physician and/or radiation oncologist 7. Pregnancy or breast feeding

Outcomes

Primary Outcomes

VT burden

Change in proportion of patients with a ≥75% reduction in VT burden at 6 months (number of VT episodes in 6 months post treatment compared to the number of VT episodes in the 6 months prior to randomisation excluding a 6-week blanking period after treatment initiation)

Time frame: 6 months

Secondary Outcomes

Recurrent sustained VT

Recurrent sustained VT ascertained by implanted cardioverter defibrillator (ICD) (VT identified and treated by the ICD with anti-tachycardia pacing (ATP) and/or internal ICD delivered shock or ≥30 seconds of VT if untreated by ICD

Time frame: 6, 12, 24 and 36 months

VT storm

VT storm (three or more documented episodes of VT within 24 hours or incessant VT)

Time frame: 6, 12, 24 and 36 months

Absolute VT burden

Absolute percentage reduction in VT burden compared to pre-ablation

Time frame: 6, 12, 24 and 36 months

Serious Adverse Events (SAE) and Adverse Events of Special Interest (AESI)

1. SAE and AESI related to effects of SBRT 2. SAE and AESI related to standard care e.g. medical anti-arrhythmic drug therapy or catheter ablation or heart transplantation

Time frame: At all time points up to 36 months

ICD shocks

Implantable Cardioverter Defibrillator shocks

Time frame: 6, 12, 24 and 36 months

Hospitalization

Cardiovascular as well as specifically heart failure and arrhythmia

Time frame: 6, 12, 24 and 36 months

All cause mortality